NCT00962156

Brief Summary

  • By tradition hydroxyethyl starch (HES) is used to obtain fast circulatory stabilisation in critically ill.
  • High molecular weight HES may, however, cause acute kidney failure in patients with severe sepsis.
  • Now the low molecular weight HES 130/0.4 is the preferred colloid in Scandinavian intensive care units (ICU) and 1st choice fluid for patients with severe sepsis.
  • HES 130/0.4 is largely unstudied in ICU patients.
  • This investigator-initiated Scandinavian multicentre trial will be conducted to assess the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis.
  • The trial will provide important data to all clinicians who resuscitate septic patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2009

Geographic Reach
4 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

August 18, 2009

Last Update Submit

July 9, 2012

Conditions

Severe SepsisSeptic Shock

Keywords

SepsisShockFluid therapyPlasma expanders

Outcome Measures

Primary Outcomes (1)

  • Mortality or dialysis-dependency

    90 days

Secondary Outcomes (13)

  • Mortality

    28 days

  • Mortality

    6 months

  • Mortality

    1 year

  • Severity organ failure assessment score

    Day 5

  • Days free of ventilation

    90 days

  • +8 more secondary outcomes

Study Arms (2)

HES 130/0.4

EXPERIMENTAL

Volume expansion

Drug: 6% Hydroxyethyl starch 130/0.4

Ringer acetate

ACTIVE COMPARATOR

Volume expansion

Drug: Ringers acetate

Interventions

6% Hydroxyethyl starch 130/0.4DRUG

Infusion for volume expansion in the ICU

Also known as: 6% Tetraspan
HES 130/0.4
Ringers acetateDRUG

Infusion for volume expansion in the ICU

Also known as: Ringerfundin / Sterofundin
Ringer acetate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients who
  • Undergo resuscitation in the ICU
  • AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)
  • AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)

You may not qualify if:

  • Age \< 18 years old
  • Previously randomised in the 6S trial
  • Allergy towards hydroxyethyl starch or malic acid
  • Treatment with \> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation
  • Any form of renal replacement therapy
  • Acute burn injury \> 10% body surface area
  • Severe hyperkalaemia, p-K \> 6 mM
  • Liver or kidney transplantation during current hospital admission
  • Intracranial bleeding within current hospitalisation
  • Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
  • Withdrawal of active therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Bispebjerg Hospital

Copenhagen, Denmark

Location

Gentofte Hosptial

Copenhagen, Denmark

Location

Glostrup Hospital

Copenhagen, Denmark

Location

Herlev Hospital

Copenhagen, Denmark

Location

Hvidovre Hospital

Copenhagen, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Esbjerg Hospital

Esbjerg, Denmark

Location

Herning Hospital

Herning, Denmark

Location

Hillerød Hospital

Hillerød, Denmark

Location

Hjørring Hospital

Hjørring, Denmark

Location

Holbæk Hospital

Holbæk, Denmark

Location

Holstebro Hospital

Holstebro, Denmark

Location

Køge Hospital

Køge, Denmark

Location

Næstved Hospital

Næstved, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Slagelse Hospital

Slagelse, Denmark

Location

Sønderborg Hospital

Sønderborg, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

Dept of Intensive Care, Helsinki University Hospital

Helsinki, Finland

Location

Dept. of Intensive Care, Kuopio University Hospital

Kuopio, Finland

Location

Dept of Intensive Care, Tampere University Hospital

Tampere, Finland

Location

Dept. of Intensive Care, Landspitali

Reykjavik, Iceland

Location

Haukeland University Hospital

Bergen, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

Intensive Care Unit, University Hospital of North Norway

Tromsø, Norway

Location

St Olavs Hospital, Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (5)

  • Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bodker KD, Badstolokken PM, Bendtsen A, Soe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bulow HH, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schoidt O, Leivdal S, Berezowicz P, Pettila V, Ruokonen E, Klepstad P, Karlsson S, Kaukonen M, Rutanen J, Karason S, Kjaeldgaard AL, Holst LB, Wernerman J; Scandinavian Critical Care Trials Group. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomised clinical trial. Trials. 2011 Jan 27;12:24. doi: 10.1186/1745-6215-12-24.

    PMID: 21269526BACKGROUND

  • Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

    PMID: 22738085RESULT

  • Ostrowski SR, Haase N, Muller RB, Moller MH, Pott FC, Perner A, Johansson PI. Association between biomarkers of endothelial injury and hypocoagulability in patients with severe sepsis: a prospective study. Crit Care. 2015 Apr 24;19(1):191. doi: 10.1186/s13054-015-0918-5.

    PMID: 25907781DERIVED

  • Perner A, Haase N, Winkel P, Guttormsen AB, Tenhunen J, Klemenzson G, Muller RG, Aneman A, Wetterslev J. Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer's acetate. Intensive Care Med. 2014 Jul;40(7):927-34. doi: 10.1007/s00134-014-3311-y. Epub 2014 May 8.

    PMID: 24807084DERIVED

  • Muller RG, Haase N, Wetterslev J, Perner A. Effects of hydroxyethyl starch in subgroups of patients with severe sepsis: exploratory post-hoc analyses of a randomised trial. Intensive Care Med. 2013 Nov;39(11):1963-71. doi: 10.1007/s00134-013-3090-x. Epub 2013 Sep 14.

    PMID: 24037226DERIVED

Related Links

MeSH Terms

Conditions

SepsisShock, SepticShock

Interventions

Hydroxyethyl Starch DerivativesLHFPL6 protein, humanRingerfundinsterofundin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Anders Perner, MD, PhD

    ICU, Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Nicolai Haase, MD

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

FI(3)NO(4)DK(18)IC(1)